Patients will receive an injection of the Cell therapy vehicle into their supraspinatus muscle and tendon at the time of rotator cuff repair.
E-CEL UVEC cells suspended in autologous plasma and combined with thrombin at the implantation site (tendon delivery).
E-CEL UVEC cells suspended in 6.0% Dextran 40 and 10.0% human serum albumin (HSA) (infusion solution) (muscle delivery).

Rotator Cuff Tears

Muscle Atrophy or Weakness

Tendon Rupture - Shoulder

Safety Issues

Local implantation of E-CEL UVEC cells at the supraspinatus tendon repair site

E-CEL UVEC

Hospital for Special Surgery

E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults

A Phase 1 Open-Label, Single-Center Investigator Initiated Trial (IIT) of E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults

The primary study outcomes are measures of local and systemic safety and toxicity via adverse event (AE) logs (post-operative day 0 to Day 11). AE are evaluated using a 5 point severity scale to grade the AE, 1 (mild) to 5 (death/ fatal).

The primary study outcomes are measures of local and systemic safety and toxicity via symptom reporting (post-operative day +90 to 1 year post-op). Symptom reporting will evaluate pain and swelling based on a 0 to 100mm visual analog scale range, in addition to further symptom reporting.

Re-tear rate based on clinical and MRI evaluation for MRI assessments of muscle and tendon quality, measured as a percentage of total volume (%).

Shoulder strength during regular intervals post-operatively up to 1 year. BioDex system 3 will measure Peak Toque in Nm, scapular plane abduction strength 0-90 degrees.

Patient-reported outcomes post-operatively up to 1 year. ASES affected vs unaffected shoulder score (each test has a maximum score of 100 points).

Hospital for Special Surgery, New York

Angiocrine Bioscience

80 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48)PO, DAILY

160 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, DAILY

320 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, DAILY

640 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, DAILY

1280 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, DAILY

2560 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID

18 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID

36 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID

72 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID

144 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID

288 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID

576 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID

750mg/m2 PO Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID

1000mg/m2 PO Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID

1280 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID

Advanced Solid Tumors

Lymphomas

CZ48 will be administered in successive cohorts of 1 patient per participating site until hints of toxicity (grade 2 or worse adverse events related to the drug) are observed. Then cohort of 3+3 patients will be treated. CZ48 will be administered orally daily for 3 weeks followed by a 1 week rest. (1 course = 4 weeks). No pre-medications will be administered. Patients will be asked to drink 2 liters of fluid daily to flush the bladder.

Camptothecin-20-O-Propionate Hydrate (CZ48)

University of Texas Health Sciences Center

port-wine stain/albumin

E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults

Phase I and Pharmacology Study of Camptothecin-20-O-Propionate Hydrate (CZ48) in Patients With Solid Tumors or Lymphoma

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